Influence of Intraoral Photobiomodulation in Individuals With Temporomandibular Joint Dysfunction

NCT02839967 | Completed DMC

• 1 other identifier: PHOTOBIOMODULATION DTM INT.
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

According to the International Association for the Study of Pain (IASP), the temporomandibular pain and dysfunction syndrome (TMD) is characterized as a subset of orofacial pain, whose signs and symptoms include pain or discomfort in the temporomandibular joints. Pain is considered one of the most common and limiting clinical manifestations. One of the most used resources to treat muscle pain is the low-level laser therapy (LLLT), However, the mechanisms responsible for the effects observed in clinical trials remain poorly elucidated, as well as therapy with light emitting diode therapy (LEDT) which, has some advantages, among them the larger area radiation point and low cost. However, its effects remain elusive in intraoral application in temporal muscle, lateral and medial pterygoid muscle. Assuming that there is need to investigate therapeutic resources that combine not only different wavelengths as well as different light sources (LED and LLLT), this study aims to evaluate the effect of photobiomodulation with a combination of different light sources on pain, joint mobility, equity and quality of jaw movements after treatment in patients with TMD. It will be made a randomized, placebo-controlled and double-blind clinical trial. Individuals participate with myogenic temporomandibular disorder, being allocated into 2 groups randomly and stratified by the method of sealed envelopes. The results will be evaluated using: RDC/TMD, digital caliper, visual analog scale, and kinematics. The protocols will be used in a 6 sessions and will be evaluated in four different moments. The analyses of the data will be performed by adopting a significance level of 5%.

Conditions

Temporomandibular Disorders

Outcome Measures

Primary Outcomes (2)

• Intensity of pain as measured by Visual analogue scale

  Visual analogue scale is a tool which allows easy measurement of the intensity of the pain, and consists of a straight line of 10 cm in length, the ends have a verbal description (without pain and worst pain ever felt, respectively), in which the volunteers will be directed to make a perpendicular dash between the two extremes that represents the level of pain she presented at that time.

  five minutes

• Measured by joint mobility

  Will be used a digital meter to assess the breadth of mandibular movement (in mm), i.e. will be measured the opening of the mouth, sides (right and left) and protrusion.

  ten minutes

Secondary Outcomes (2)

• Functional as measured by Patient specific Functional scale

  ten minutes

• quality of life measured by questionnaire (WHOQOL-BREF)

  ten minutes

Study Arms (2)

Photobiomodulation group

EXPERIMENTAL

For the purposes of photobiomodulation is used a portable cluster 9 PainAway ® diodes manufactured by Multi Radiance Medical ® (Solon, OH-USA), and 1 905 nm diode LASER, 4 875 nm LED diodes and 4 670 nm diodes LED, 4 cm2 beam, emitting an energy of 39.27 J.

Other: Photobiomodulation

Photobiomodulation placebo group

PLACEBO COMPARATOR

To provide the "blinding" of the participants of the study we will use two identical photobiomodulation equipment supplied by the manufacturer, being an active and another a placebo, but both have identical light and sound device (do not send energy and heat, non-coherent light without biological effect). The devices are named in X and Y for a researcher who does not participate in treatment and assessments.

Other: Photobiomodulation placebo

Interventions

Photobiomodulation OTHER

Intraoral photobiomodulation is applied in the temporal, medial and lateral pterygoid, bilateral, totaling 4 points of application of phototherapy. The researcher who will perform the treatments will receive the equipment with the stylus activates and pre-programmed dose, an eye protection (glasses, opaque) will be used by the participants, to protect the eyes, because the same does not cause any sensation to volunteer. The technique is used, contact an area. The individual is positioned supine on a stretcher, with the legs supported on a foam roller 20 cm in diameter, the head supported on a pillow, to accommodate her comfortably in a resting posture, prompted the opening of the mouth and placing the tip of photobiomodulation in sections as described below, with 2 minutes interval between one application and another for rest with the mouth closed.

Photobiomodulation group

Photobiomodulation placebo OTHER

The volunteers will be subjected to the same Group intervention, Photobiomodulation and the researcher will receive the equipment unaware if the pen that will apply the phototherapy is active or placebo, only the research coordinator will have this knowledge, and for this group the researcher will receive placebo pen. Fits the caveat that, when the voluntary participation, will be held with the active pen treatment.

Photobiomodulation placebo group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with disfunction temporomandibular.
• Limitation of mandibular opening below 40 mm.
• score of masticatory muscle pain greater than 3 cm in accordance with EVA.

You may not qualify if:

• women who have dental failures, total or partial prosthesis.
• systemic diseases .
• history of trauma to the face and or ATMor the ATM dislocation history.
• orthodontic treatment and/or medicated that affects the musculoskeletal system.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University of Nove de Julho

São Paulo, São Paulo, 01415000, Brazil

Location

Related Publications (1)

• Herpich CM, Leal-Junior ECP, Politti F, de Paula Gomes CAF, Dos Santos Gloria IP, de Souza Amaral MFR, Herpich G, de Azevedo LMA, de Oliveira Gonzalez T, Biasotto-Gonzalez DA. Intraoral photobiomodulation diminishes pain and improves functioning in women with temporomandibular disorder: a randomized, sham-controlled, double-blind clinical trial : Intraoral photobiomodulation diminishes pain in women with temporomandibular disorder. Lasers Med Sci. 2020 Mar;35(2):439-445. doi: 10.1007/s10103-019-02841-1. Epub 2019 Jul 19.

  PMID: 31325122 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Daniela ap Biasotto-Gonzalez, Phd

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: July 21, 2016
• Study Start: September 25, 2016
• Primary Completion: May 10, 2017
• Study Completion: January 20, 2018
• Last Updated: January 28, 2019

Record last verified: 2019-01

Locations

BR (1)